Portable transcutaneous magnetic stimulator and systems and methods of use thereof

ABSTRACT

A transcutaneous magnetic stimulation (tMS) device is provided for modulating nerve function and chronic pain management, and includes a tMS stimulator, a control module in wired and powered communication with the tMS stimulator, and a portable electronic device in wireless communication with the control module to receive, generate and transmit feedback and control settings relating to a treatment session. The tMS stimulator may be a flexible figure-of-eight coil configured in different sizes and shapes to provide varying pulse and magnetic field strengths for mobile, home, or clinical uses, and also include guidance tools and measurement sensors to aid in positioning and directing the tMS stimulator to a target area for treatment.

RELATED APPLICATIONS

This is a continuation of U.S. application Ser. No. 16/533,653, filedAug. 6, 2019, issued as U.S. Pat. No. 11,273,317, which is acontinuation of U.S. application Ser. No. 14/775,490, filed Sep. 11,2015, issued as U.S. Pat. No. 10,369,373, which is a 371 national stagefiling of International Application No. PCT/US2014/023808, filed Mar.11, 2014, which claims the benefit of U.S. Provisional Application No.61/776,050, filed Mar. 11, 2013, each of which is incorporated herein byreference in its entirety.

FIELD OF THE INVENTION

The present invention relates to a device, system, and method fornon-invasive and self-administered treatment of peripheral pain, andmore particularly to a portable device, system and method fortranscutaneous magnetic stimulation (tMS).

BACKGROUND OF THE INVENTION

Peripheral nerve injury may result in the development of chronicintractable pain. Some patients prove unresponsive to conservative painmanagement techniques. Peripheral Nerve Stimulation (PNS) has developedas a successful therapy for pain management when the pain is known toresult from a specific nerve. PNS is based in part on the Melzack-Wallgate control theory of pain. Sweet and Wespic first used electricalstimulation of peripheral nerves in the 1960s to mask the sensation ofpain with a tingling sensation (paresthesia) caused by the electricalstimulation. Subsequent refinements in the technology, surgicaltechnique and patient selection have led to improved long term results.

Efforts have been made to treat psychiatric disorders withperipheral/cranial nerve stimulation. Recently, partial benefits withvagus nerve stimulation in patients with depression have been describedin U.S. Pat. No. 5,299,569. Another example of electrical stimulation totreat depression is described in U.S. Pat. No. 5,470,846, whichdiscloses the use of transcranial pulsed magnetic fields to treatdepression. U.S. Pat. No. 5,263,480 describes that stimulation of thevagus nerve may control depression and compulsive eating disorders andU.S. Pat. No. 5,540,734 teaches stimulation of the trigeminal orglossopharyngeal nerves for psychiatric illness, such as depression.

Another example of peripheral nerve stimulations include, for example,stimulating the C2 dermatome area to treat occipital neuralgia, whichmay be defined generally as an intractable headache originating in theback of the head in the vicinity of the C2 dermatome area (U.S. Pat. No.6,505,075). This method of delivering electrical stimulation energy tothe C2 dermatome area to treat occipital neuralgia involves positioningstimulation electrodes of an implantable electrical stimulation leadwith at least one electrode in the fascia superior to in a subcutaneousregion proximate the C2 dermatome area.

The use of electrical stimulation for treating neurological diseases,including such disorders as movement disorders including Parkinson'sdisease, essential tremor, dystonia, and chronic pain, have also beenwidely discussed in the literature. It has been recognized thatelectrical stimulation holds significant advantages over lesioning sincelesioning destroys the nervous system tissue. In many instances, thepreferred effect is to modulate neuronal activity. Electricalstimulation permits such modulation of the target neural structures and,equally importantly, does not require the destruction of nervous tissue.Such direct electrical stimulation procedures include electroconvulsivetherapy (ECT), transcranial direct current stimulation (tDCS) and vagalnerve stimulation (VNS). In addition, indirect cortical (brain)electrical stimulation can be achieved via transcranial magneticstimulation (TMS).

Traditional treatment options, for some forms of intractable pain(occipital pain, traumatic brain injury) that have proven to beresistant to medications, usually involve chemical, thermal or surgicalablation procedures following diagnostic local anesthetic blockade.Surgical approaches include neurolysis or nerve sectioning of either theC2 dermatome area in the occipital scalp or at the upper cervical dorsalroot exit zone (extradural). Foraminal decompressions of C2 roots aswell as C2 ganglionectomy have also been effective in reported cases.

Transcranial magnetic stimulation (TMS) was first introduced in 1985.TMS provided a non-invasive, safe, and painless method of activating thehuman motor cortex and assessing the integrity of the central motorpathways. Since its introduction, the use of TMS in clinicalneurophysiology, neurology, neuroscience, and psychiatry has spreadwidely.

TMS is based on the principle of electromagnetic inductions. If a pulseof current passing through a coil placed over a person's head hassufficient strength and short enough duration, rapidly changing magneticpulses are generated that penetrate scalp and skull to reach the brainwith negligible attenuation. These pulses induce a secondary ioniccurrent in the brain. The site of stimulation of a nerve fiber is thepoint along its length at which sufficient current to causedepolarization passes through its membrane. Depending on the stimulationsetting, single stimuli can either excite or inhibit neuronal functions.

Magnetic stimulation provides a non-invasive method for modulating nervefunction and chronic pain management. Current methods of magnetictreatment for pain can be delivered via either static or dynamicmagnetic field. While the efficacy of static magnetic field treatmentsuch as magnetic bracelets has yet to be substantiated, studiesinvolving the use of repetitive transcranial magnetic stimulation(dynamic magnetic flux) have yielded appreciable evidence support themerits of the device in relieving pain. Aside from stimulating thebrain, the utilization of dynamic magnetic flux in transcutaneousstimulation for pain relief has not been fully explored. Thisunder-utilization is the result of a number of issues: 1) the currentcommercially-available magnetic stimulators are physically very bulky;2) the coils usually require additional cooling units to preventoverheating; 3) the devices are too expensive to be accessible to thegeneral public; and 4) operating the device requires special trainingand clinical privilege. These physical limitations, cost and therequirement of special training restrict the current scope of use ofthis non-invasive means of pain management outside of healthcarefacilities.

Accordingly, the need remains for a device that is affordable and easyto use that makes tMS, an effective tool for management of chronic pain,readily available.

SUMMARY

In an exemplary embodiment, a transcutaneous magnetic stimulation (tMS)device includes a tMS stimulator, a control module in wired and poweredcommunication with the tMS stimulator, and a portable electronic devicein wireless communication with the control module to receive, generateand transmit feedback and control settings relating to a treatmentsession. The tMS stimulator may be a flexible figure-of-eight coilconfigured in different sizes and shapes to provide varying pulse andmagnetic field strengths for mobile, home or clinical uses, and alsoinclude guidance tools and measurement sensors to aid in positioning anddirecting the tMS stimulator to a target area for treatment.

In one embodiment, a transcutaneous magnetic stimulation (tMS) devicecomprises a tMS stimulator configured to deliver a magnetic pulse withat least one insulated magnetic coil; and a control module in poweredcommunication with the tMS stimulator configured to control a pulse rateand magnetic field of the tMS stimulator.

In another embodiment, a method of treating a patient usingtranscutaneous magnetic stimulation (tMS) comprises the steps ofconfiguring a control module to deliver a specified pulse rate andmagnetic strength with a tMS stimulator; positioning the tMS stimulatorover a target area of a human body; and delivering a magnetic pulse atthe specified pulse rate and magnetic strength using the tMS stimulator.

In a further embodiment, a system for delivering a transcutaneousmagnetic stimulation (tMS) therapy comprises a tMS device including atMS stimulator and control module configured to deliver a magneticpulse; a portable electronic device in wireless communication with thetMS device and configured to receive data from the control modulerelating to the delivered magnetic pulse and feedback from a userrelating to the delivered magnetic pulse and their rating of pain at thetreatment site; and a remote server in communication with the portableelectronic device configured to receive the data from the control modulerelating to the delivered magnetic pulse and the feedback from the userrelating to the delivered magnetic pulse.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 digrammatically illustrates an exemplary embodiment of atranscutaneous magnetic stimulator (tMS) according to the invention.

FIG. 2 is an illustration of a tMS stimulator, according to oneembodiment of the invention.

FIGS. 3A-3G are illustrations of a figure-of-eight coil within the tMSstimulator and a coil rotation mechanism, according to one embodiment ofthe invention.

FIG. 4 is an illustration of an exemplary control module for the tMSstimulator device.

FIGS. 5A-5C illustrate alternative configurations of the tMS.

FIG. 6 is an exemplary circuit diagram for carrying out the functions ofthe tMS.

FIGS. 7A-7C illustrate sample graphical user interfaces on a portableelectronic device configured to communicate with the tMS.

FIG. 8 diagrammatically illustrates an exemplary arrangement forcontrolling and tracking treatments performed by an embodiment of thetMS.

FIG. 9 is an flow diagram for an exemplary tMS treatment sequence.

FIG. 10 is a graph comparing results from use of the inventive tMS,TENS, and a placebo for treatment of myofacial pain.

FIG. 11 is a table summarizing pain reduction experienced by patientswith neuroma or post-traumatic neuropathic pain states after treatmentwith the tMS.

FIG. 12 is a block diagram illustrating an embodiment of acomputer/server system for implementing the inventive method.

DETAILED DESCRIPTION OF EMBODIMENTS

The transcutaneous magnetic stimulator (tMS) device described herein isconfigured to modulate nerve function and reduce pain. Thetranscutaneous magnetic stimulation (tMS) device that includes a tMSstimulator, a control module in wired and powered communication with thetMS stimulator, and a portable electronic device in wirelesscommunication with the control module to receive, generate and transmitfeedback and control settings relating to a treatment session. The tMSstimulator may be a flexible figure-of-eight coil configured indifferent sizes and shapes to provide varying pulse and magnetic fieldstrengths for mobile, home, or clinical uses, and also include guidancetools and measurement sensors to aid in positioning and directing thetMS stimulator to a target area for treatment.

I. Transcutaneous Magnetic Stimulator Device

FIG. 1 illustrates one embodiment of a tMS device 100, including a tMSstimulator 102 connected with a control module 104. The control module104 may include one or more selection knobs 106 to adjust the varioussettings of the tMS stimulator and a display screen 108 to display thesettings, status, and other indicators. The tMS stimulator 102 may bepositioned over a portion of a human body 110, animal or other livingtissue where the magnetic stimulation is then applied.

The tMS stimulator 102 produces small electrical currents around aneuroma or nerve entrapment without anesthetics, and may be an insulatedcoil which can be held over a target treatment area either with orwithout contacting the affected area. This method of painneuromodulation provides a major advantage in treating patients withincreased sensitivity to non-noxious stimuli (allodynia), as thetreatment does not require direct device-patient contact or directtissue penetration. When a current is passed around the coil, a dynamicmagnetic flux will pass through the skin and into the first fewcentimeters of the skin without attenuation. In one embodiment, the coilis shaped into a figure-of-eight coil that gives a focused dynamicmagnetic flux from the center of the coil to the target site which canbe marked with an extended optical cross-hair in order to target aspecific area on the body. This dynamic magnetic flux induced neuronalstimulation is far more focused than other direct current stimulationmodalities such as a transcutaneous electrical nerves stimulator (TENS).

In one embodiment, the tMS stimulator 102 operates within a frequencyrange that is variable from approximately 0.2 Hz to 5 Hz. The frequencyrange may be divided into a low frequency stimulation range fromapproximately 0.2 Hz-1 Hz and a high frequency range from approximately1 Hz to 5 Hz. The magnetic pulse field strength has a continuousstimulation capacity of up to 3 Tesla. A biphasic waveform is moreeffective with regard to threshold of excitation and response amplitudewhen compared to a traditional monophasic waveform. In one embodiment(see FIG. 3G), a magnetic core of permalloy, Mu-metal, or otherferromagnetic compound may be assembled in the center of the coil tofurther increase the strength of the magnetic flux. In one embodiment,the magnetic core allows for a decrease in the current needed toeffectuate a treatment from approximately 1200V to 700V.

One embodiment of a tMS stimulator 102 is illustrated in FIG. 2, withfurther illustrations of the coil housing illustrated in FIGS. 3A-3G. Inthe embodiment of the stimulator 102 illustrated in FIG. 2, the tMSstimulator 102 includes a flexible figure-of-eight coil encased in acoil housing 112 that can either be handheld by a user or mounted to abase or other mounting device at a handle portion 114. In oneembodiment, the coil housing 112 measures approximately 5 inches inlength, approximately 2.5 inches wide and approximately 1.5 inches deep.The handle portion 114 of the tMS stimulator may extend approximately7.5 inches from the coil portion and allow for the tMS stimulator to behandheld or mounted during use. The tMS stimulator 102 may also includea tMS display screen 116 to display information on the positioning andtreatment, such as a tracking distance to a target region or treatmentparameters related to the tMS settings. The tMS stimulator 102 may alsoinclude control buttons 118 for controlling the settings and otherparameters of the tMS stimulator. The display screen 116 and the buttons118 may be capacitive touch or capable of receiving other touch inputs.

A transparent illustration of the coil housing 112 is illustrated inFIG. 3A, showing the configuration of the figure-of-eight coil 120 witha left coil 120A and right coil 120B. In one embodiment, thefigure-of-eight coil 120 may rotate internally up to approximately 30degrees in order to adjust a focal point of the treatment by redirectingthe magnetic field. The focal point may be focused to withinapproximately 3-5 millimeters in the rotated configuration of FIG. 3A,which illustrates a rotated configuration of the figure-of-eight coil120, which is rotated via a central gear mechanism 122 attached to acurved mounting piece 124 (see FIG. 3C). FIG. 3B is an exploded viewillustration of the coil housing 112, illustrating a top housing portion112A and a bottom housing portion 112B which are fitted around the leftcoil 120A and right coil 120B.

FIG. 3C is an exploded view illustration of the figure-of-eight coil 120separated from the gear mechanism 122 and curved mounting pieces 124simply for illustration purposes to show the shape and interaction ofthe gear mechanism 122 and curved mounting pieces 124 with the coil 120.FIG. 3D illustrates the gear mechanism 122 and curved mounting pieces124 in communication with their respective coils 120A and 120B in anun-rotated configuration.

FIG. 3E illustrates the mechanics of the gear mechanism 122, which maybe driven by a small motor 126 attached with a central gear 128A. One ofthe coils 120A may be connected with the gear mechanism through a singlesecondary gear 128B, while the opposing coil 120B is connected with thegear mechanism through two secondary gears 128C and 128D in order toeffectuate an opposite direction of rotation of the coils so that theyboth rotate inward to focus on a single target point. For simplicity ofillustration only, the secondary gears 128C and 128D are not illustratedin other figures. FIG. 3F is an illustration of the figure-of-eight coil120 in the rotated configuration after the motor 126 actuates the gearsto rotate the coil 120 via the mounting pieces 124.

FIG. 3G is a three dimensional graphical illustration of one embodimentof the coil 120 with a respective magnetic core 130A and 130B disposedwithin each respective coil 120A and 120B, as described above. Thecurved mounting pieces 124 are also more clearly shown disposed againstan outer side wall of the coils 120. The curved mounting pieces may bemetal pieces which are attached to the coils via screws or any otherpractical attachment means.

The tMS stimulator 102 may also include a light source (not shown) suchas an LED on an application side of the coil portion that faces the body110 to guide a center of magnetic flux generated by the coil to a targettreatment area. An accelerometer may also be implemented in the tMSstimulator 102 to detect magnitude and direction of the probeacceleration to sense orientation, vibration, shock and falling in orderto turn off the device during deviations from treatment locale.

A magnetometer may also be included to measure the strength anddirection of magnetic fields generated by the stimulation coils tooptimize accuracy and intensity of treatments. Further, a proximitysensor may be included to detect and confirm that the target region oftreatment is within the appropriate range of the tMS stimulator 102 toprecisely deliver treatment to achieve the greatest results.

The tMS stimulator 102 may be designed with a thermode to automaticallyshut off the stimulation probe in the the event of overheating from bothinternal and external factors. For efficiency, controller software inthe control module 104 may utilize a negative-feedback method and detectunusual heating patterns to prevent damage to the device, or injury tothe user, by warning the user and turning off the device.

In one embodiment, guidance for proper positioning of the target regioncan be provided by a combination of marks applied to the user's skin,preferably using a safe marking material that is invisible ornearly-invisible under normal light conditions. For example, the ink canbe fluorescent visible only under focused UV light, e.g., a black light.The device may include a UV light source that is optically focused tocoincide with the optimal flux location from the stimulation probe. In apreferred embodiment, the UV light source may be an LED that produceslight at around 400 nm, making it more compact, rugged and easilyportable, while generating light that is near the lower end of UVwavelengths and, therefore, safer for repeated exposure.

The control module 104 is configured with hardware and software toprecisely control the tMS stimulator 102 and provide data relating tothe treatment in real-time and post-treatment. One embodiment of thecontrol module 104 is illustrated in further detail in FIG. 4. Althoughthe control module 104 is illustrated with one or more control knobs 106to adjust the tMS stimulator settings, a touchscreen display 108 mayinstead be used to eliminate the need for physical control buttons. Thetouchscreen display may present tMS stimulator information 132 orconnection status indications 134 pertaining to connections with theportable electronic device or another network device. In one embodiment,the control module 104 may be equipped with a handle (not shown) forportability and powered by AC electricity or a battery. The controlmodule may be formed with a thermoplastic housing 136 to isolate a userfrom the high-voltage components inside. In one embodiment, the controlmodule 104 may be equipped with rechargeable batteries (Lithium-ion &Sodium-ion) or graphene supercapacitors to increase mobility. Thecontrol module 104 displays the pulse width, amplitude and frequency ofthe treatment, which can be adjusted via one or more separate controlknobs. The output of the device is 3 T at 1 Hz, with 20 kTesla/sec.instantaneous flux.

The control module 104 may also include a wireless transmitter/receiverand corresponding software to provide a wireless connection with anotherdevice, for communication, tracking and management of treatment,remotely programming treatment parameters, troubleshooting assistance,updating software and to ensure compliance. In an exemplary embodiment,low energy BLUETOOTH® 4.0 technology provides connection to a mobiledevice, e.g., a smart phone or tablet computer, for tracking andmanaging treatment and results to optimize therapeutic parameters andmaximize analgesic efficacy.

FIGS. 5A-5C illustrate alternative embodiments of the tMS device 100designed for different applications. FIG. 5A illustrates a mobile tMSdevice 100A with a portable control module 104A and tMS stimulator 102Awhich provide a reduced output of approximately 1.5 Tesla and 3 pulsesper second (PPS). FIG. 5B illustrates a larger tMS device 100B with alarger control module 104B and tMS stimulator 102B configured forin-home use that provides approximately 3 Tesla and 5 PPS. A clinicaltMS device 100C is provided in FIG. 5C, and illustrates a control module104C with a larger display screen capable of displaying real-time signaldata on the applied fields, as well as a tMS stimulator 102C mounted toa floor-mounted positioning arm that can be used to precisely directtreatment to a particular part of the body for a user sitting in atreatment chair. In one embodiment, the clinical tMS device 100C may becapable of outputting approximately 4 Tesla and 50 PPS.

FIG. 6 illustrates the circuit design for operating the tMS device 100.The circuitry has been built to continuously monitor and adjust poweroutputs to ensure efficacy of the treatment and safety of the user.Crucial circuit components are tested in every power cycle, before andafter each treatment administration with the primary hardwaresupervisory circuits and secondary software monitoring systems incommunication with the Microcontroller unit. The circuitry boots instages and if a failure is detected, safety interrupts will discontinuethe booting process, shutdown device operation, and ask for servicing.The circuitry inside the control module 104 may also include parallelhigh voltage chargers, each capable of up to 1600 watt power output,energizing capacitor banks, with up to 2200 uF energy storage capacity,and discharging hardware to decrease loss of performance and increasereliability. The capacitor bank inside control module 104 may range involtages from −2000 to +4500 volts DC in order to conserve energy andoptimize performance. The maximum repetitive controllable on-statecurrent within the control module and stimulation coil may reach up to4000 volts DC. In one embodiment, multiple high power convertingthyrisitors may be stacked to achieve the perfomance requirements ofthis pulsed power application. Heat from inductance may be managedinternally with small, electrically powered, forced-air cooling systemsutilizing continuous duty DC blower fans operating at up to 5200 RPM.

In one embodiment, the tMS system can be password- orbiometrically-protected to ensure access only by approved users of thedevice.

II. Portable Electronic Device

In one embodiment, a portable electronic device may be utilized with thetMS to provide for wireless control of the tMS device and analysis oftreatments. The portable electronic device may be a portable computingdevice such as a smartphone, tablet, laptop or wearable device that isconfigured to wirelessly communicate with the tMS, provide a visualinterface for displaying information about the control of the tMS andtreatments performed, and inputs (such as a touchscreen) for the user tointeract with the portable electronic device. The portable electronicdevice may be connected with the tMS via a wireless connection protocolsuch as Bluetooth®, NFC, or a proprietary device-specific network suchas the 2Net™ Platform® for wireless health, although the list should notbe limited thereto. In one embodiment, an internal modem with anomnidirectional antenna may be utilized to connect with IEEE 802.16family wireless hotspots and 3G telecommunications networks such asWiMAX. These networks may be utilized to passively transmit usage dataon the device to a remote server for monitoring the usage andperformance of the device. Updates to the settings, programs andconfiguration of the hardware, software and firmware may be providedover these networks, whether by a technician who is improving theperformance of the device or by a physician updating a patient'streatment session parameters. A wireless network connection may also beutilized for tracking the device if lost or stolen.

FIGS. 7A-7C illustrate graphical user interfaces (GUIs) that may bedisplayed on a touchscreen display of a smartphone 212 to allow the userto input the settings 214 for their treatments and provide apre-treatment pain score 216 and post-treatment pain score 218. Thescores can then be correlated with the input settings 214 to determinewhich tMS settings provide the best reduction in pain. Additional notesrelating to the treatment may be entered by the user in a notes tab 220.

In FIG. 7A, the user can select the levels of their tMS settings 214,including frequency, duration, pulses and amplitude. The settings mayalso be automatically transmitted from the tMS before, during or after atreatment session so the user can instantly provide feedback related tothe session. In one embodiment, this interface may also allow the userto control the tMS device for executing a treatment session. FIG. 7Billustrates a pain score interface where the user inputs a pre-treatmentpain score 216, while FIG. 7C illustrates the interface where thepatient inputs a post-treatment pain score 218. The differences betweenscores can then be compared with the settings 214 for the particulartreatment to determine how effective the treatment was at the particularsettings. The user may add notes 220 to further explain the reasons forthe scores or other information relevant to the treatment, and thesenotes 220 may be transmitted to a healthcare professional along with thetreatment settings and pain scores, as will be described in furtherdetail below.

III. Systems for Monitoring Patient Progress

A system for providing treatment using the tMS is illustrated in FIG. 8,where the the portable electronic device 212 is configured tocommunicate both with the tMS device 204 and with a remote server 222,where data related to the treatment sessions, user feedback, devicesettings, etc. can be transmitted for analysis at a remote location. Thedata received at the remote server may be stored in a database 224,where the data for individual users or a group of users may be analyzedto determine the effectiveness of treatments on certain types of pain,symptoms, body parts, etc. The remote server 222 may also be configuredto transmit treatment settings to the portable electronic device 212,which can then be transmitted directly to the tMS in order to provideupdated treatment plans and settings based on the user feedback, thusavoiding the need for the user to visit with a healthcare provider inperson in order to update their treatment program.

IV. Exemplary Methods

An exemplary method of providing tMS is illustrated by the flow diagramin FIG. 9. In a first step 602, the control module is configured withthe settings for a treatment session, including the frequency, duration,pulse and amplitude. The tMS stimulator is then positioned adjacent to abody part which has been identified for treatment in step 604, using anyone or more of the positioning aids described above. Once the tMSstimulator is correctly positioned, the treatment session can be started(step 606). During and after the treatment session, feedback may beobtained (in step 608) from the control module or the user (via theportable electronic device) to ensure that the device is performingadequately and that the user is experiencing a decrease in pain. In step610, the feedback may be transmitted to a remote location or storedlocally for analysis by the user or a healthcare provider, and in step612, the treatment plan or device settings may be adjusted as a resultof the analysis.

V. Applications

The applications for the tMS device are numerous and not limited simplyto basic physical pain sensations. In one embodiment, the device may beutilized for treatment of post-traumatic neuroma/nerve entrapment pain.In addition to treatment of neuroma, preliminary data for using tMS fortreating myofacial pain is also available. Smania, et al. (“Repetitivemagnetic stimulation: a novel therapeutic approach for myofacial painsyndrome”, J. Neurol. 252(3): 307-314, 2005) published a study in 2005documenting the result of tMS in comparison the TENS and placebotreatment. The result is summarized in FIG. 10, which shows changes 700in the NDPVAS scale 702 in the rMS 704, TENS 706 and placebo groups 708.The asterisk indicates statistically significant differences. FIG. 11 isa table illustrating an amount of pain reduction experienced by patientsafter treatment with the tMS.

Additional applications include pre-local anesthetic/skin penetrationanalgesia, as injection of local anesthetic into peripheral tissue ofteninduces unpleasant stinging and painful sensation for patients. Manypractitioners deal with this discomfort by application of chloroethane(“freeze spray”) during the injection; however, chloroethane has thedrawbacks of being flammable and narcotic. The tMS device could providesignificant benefit in clinical uses such as peripheral IV placement,dental procedures, pediatric procedures which require skin penetration,or any outpatient pain or non-pain related procedure.

In one embodiment, the device can be used as a self-administerednon-invasive treatment for pain. The potential pain treatment/anesthesiaapplication of the device includes: myofascial (muscle) pain, nerveentrapment pain, pain related to nerve injury, pain related to muscleinjury, pain related to muscle fatigue, pain related to surgicalincision, pain related to nerve sensitivity, pain related to neuropathicpain, surgical scar pain, neuroma pain, skin anesthesia in lieu of localanesthetics, skin anesthesia for any procedure requires skinpenetration, surgical anesthesia prior to surgical incision, painrelated to pre and post-dental procedure, pain related to inadequateblood circulation, minimizing pain prior to local anesthetic injection,minimize pain prior to any needle or instructmental skin penetration,physical therapy, occupational therapy and improving muscle or jointrange of motion.

Recently the use of tMS has been shown to be beneficial in managingintractable central neuropathic states and headaches. tMS is also knownto facilitate nerve repair/regeneration. While high frequency tMS (>1Hz) results in neuronal excitation, low frequency tMS (<1 Hz) results inneuronal inhibition. Therefore, low frequency tMS can also be applied asa treatment option for managing a state of neuronal hypersensitivityknown to exist in neuroma/nerve entrapment.

VI. Case Studies

Over twenty patients with pain due to peripheral nerve injury weretreated with transcutaneous magnetic stimulation. 90% of these patientshad failed medication and injection therapies. The overall long termpain reduction using the inventive system and method is about 80%, witha maintenance treatment given at a four-to-six week interval.

A case series summary describing the treatment outcome in 5 patients isdescribed below. The five patients exhibited post-traumaticneuroma/nerve entrapment pain. Patients were selected based on theirhistory of traumatic nerve injury, physical finding of neuroma withpalpation near the site of injury, reproducible paresthesia indistribution of the injured nerve with palpation and prior history ofinadequate pain relief with oral or topical analgesics, and localsteroid and local anesthetics injection.

Low frequency (0.5 Hz) tMS was developed over the site of neuroma infive patients who have failed both steroid injection and conventionalpain medications. 400 pulses of stimulation were delivered per treatmentsession. Each patient received 3-4 sessions of treatment over a periodof two months. Pre and post intervention spontaneous pain levels wereassessed with a numerical rating pain scale (NRS).

Average pre and post scores (±SD) on the NRS were 5.00 (±1.41) and 0.80(±1.10) respectively, with an average pain reduction of 84% (±21.91) inthe NRS after three to four treatments within two months. This analgesiceffect appeared to be sustainable with repeated treatment delivered at a6 to 8 week duration. Pre-treatment tactile allodynia found in threepatients resolved after the initial 2 month treatment session.

The study demonstrates that tMS offers an innovative and non-invasivemeans of neuromodulation in managing peripheral neuropathic pain viadynamic magnetic flux.

Example 1: A 62 year old male patient presented with left groin pain.Patient had a history of inguinal hernia repair surgery 5 years prior topresentation. Pain was described as continuous, throbbing, worse withactivity and at a level of 7 in a 0-10 Numerical Pain Rating Scale(NRS). Tactile allodynia to light stroking from a foam paint blush waspresent prior to the intervention. Patient was diagnosed with left groinneuroma based on physical examination finding of palpable neuroma (1.5cm×1 cm) and paresthesia in the distribution of the genital branch ofthe left genitofemoral nerve. A CT scan showed no inguinal herniarecurrence. He had previously tried massage therapy, ibuprofen,naproxen, FLEXERIL®, and most recently DEPOMEDROL® and local anestheticinjections 4 times with minimal benefit. Subsequently local tMS therapywas initiated with frequency of 0.5 Hz and 75% amplitude and patient'spre-treatment and post-treatment levels were 4 and 0, respectively.Subsequently local tMS therapy was initiated at 0.5 Hz. 400 pulses weredelivered over the site of the neuroma with each treatment. After 4sessions of tMS treatment over a period of two months, his spontaneouspain level decreased to 0/10 NRS. He was treated at intervals rangingfrom 2 to 4 weeks with improvement noted in pain scores consistentlyboth immediate and few weeks post-treatment. His tactile allodyniaresolved, and he remained pain free with maintenance treatment at thesame setting every 8 weeks.

Example 2: A 41 year old female initially presented to clinic forbotulism toxin injections for chronic migraine treatment but was foundto have chronic pain in right foot from plantar nerve entrapment. Aneuroma (0.5 cm×0.5 cm) was identified with palpation on physicalexamination. With deep palpation over the neuroma, the pattern ofparesthesia was reproducible along the medial plantar nerve. Priortreatment modalities included cortisone injections, topical capsaicin,lidocaine but no significant change was seen in pain level. tMStreatment was attempted with initial pain score of 5 and post-treatmentscore of 0. She required repeat treatments at time intervals of four toseven weeks and her pre-treatment pain scores remained 1 to 2 at returnvisits. The treatment parameters used were frequency of 0.5 Hz, 65%amplitude with 20 pulses per train and average of 20 trains. She is nowable to function as a full time veterinarian with barely noticeable painin her foot.

Example 3: A 51 year old female with history of Crohn's disease andmultiple abdominal surgeries presented with right lower quadrantabdominal pain. She was diagnosed with abdominal nerve entrapment withinitial pain score of 5. Two neuromas (1.5 cm×1.25 cm) and 1.5 cm×1.0cm) were identified with palpation. Paresthesia could be elicited withpalpation over the neuroma. She received tMS treatments with frequencyof 0.5 Hz and amplitude of 60% at incisional scar and right lowerquadrant abdominal region. Initially she was treated every 2 weeks andlater her treatments were scheduled every 4-6 weeks. Overall, heraverage post-treatment pain score ranged from 0 to 2.

Example 4: A 56 year old male presented with chronic elbow pain withhistory of left ulnar nerve submuscular transposition. A palpableneuroma (1.0 cm×0.75 cm) was identified with physical examination.Paresthesia along the ulnar aspect of the left forearm could be elicitedwith movement of the elbow or palpation over the neuroma. He wasdiagnosed with left elbow neuroma at initial consult visit and physicalexam findings were significant for tenderness to palpation over tricepinsertion site. His prior treatment modalities utilized were VICODIN®,gabapentin, meloxicam, steroid injections and chiropractic adjustmentswithout significant benefit. tMS treatment was initiated withpre-treatment pain score of 3 and parameters used were frequency of 0.5Hz and amplitude of 60 to 80% with 20 pulses per train and average of 20trains. Patient's post-treatment scores were zero and he receivedtreatment every six to eight weeks.

Example 5: A 25 year old male presenting with chronic left groin pain,radiating to anterior and medial thigh, with a history of left inguinalhernia surgery 3 years prior to presentation. The physical exam wassignificant for tenderness with deep palpation to L groin and flexionelicited pain to left inguinal region as well as up to knee level. Hewas diagnosed with left inguinal nerve entrapment and his initialpre-treatment pain score was 5. Prior attempts at treating his conditionincluded ibuprofen, LYRICA®, amitryptyline, gabapentin, lidocaine patchand steroid injections. tMS treatment was initiated with frequency of0.5 Hz and amplitude of 60-70% with 20 pulses per train and averagenumber of 20 trains. Patient reported pain relief with pain scores of 0to 2 when treatments were scheduled three to four week intervals. Hispre-treatment scores ranged from 2 to 4 and post-treatment scores werezero.

A proposal for conducting a sham controlled randomized study iscurrently being prepared for IRB approval.

VII. Computer-Implemented Embodiment

FIG. 12 is a block diagram that illustrates an embodiment of acomputer/server system 900 upon which an embodiment of the inventivemethodology may be implemented. The system 900 includes acomputer/server platform 901 including a processor 902 and memory 903which operate to execute instructions, as known to one of skill in theart. The term “computer-readable storage medium” as used herein refersto any tangible medium, such as a disk or semiconductor memory, thatparticipates in providing instructions to processor 902 for execution.Additionally, the computer platform 901 receives input from a pluralityof input devices 904, such as a keyboard, mouse, touch device or verbalcommand.

The computer platform 901 may additionally be connected to a removablestorage device 905, such as a portable hard drive, optical media (CD orDVD), disk media or any other tangible medium from which a computer canread executable code. The computer platform may further be connected tonetwork resources 906 which connect to the Internet or other componentsof a local public or private network. The network resources 906 mayprovide instructions and data to the computer platform from a remotelocation on a network 907. The connections to the network resources 906may be via wireless protocols, such as the 802.11 & 802.16 standards,Bluetooth® or cellular protocols, or via physical transmission media,such as cables or fiber optics. The network resources may includestorage devices for storing data and executable instructions at alocation separate from the computer platform 901. The computer interactswith a display 908 to output data and other information to a user, aswell as to request additional instructions and input from the user. Thedisplay 908 may therefore further act as an input device 904 forinteracting with a user.

1. A transcutaneous magnetic stimulation (tMS) device, comprising: a tMSstimulator configured to deliver a focused pulse of magnetic flux to atarget body area, the tMS stimulator including at least one insulatedmagnetic coil and a capacitor bank of up to 2200 uF energy storagecapacity; and a control module in powered communication with the tMSstimulator configured to control a pulse rate and a magnetic field ofthe magnetic flux delivered to the target body area to treat peripheralnerve pain.
 2. The tMS device of claim 1, wherein the at least oneinsulated magnetic coil comprises a pair of magnetic coils disposedwithin a housing.
 3. The tMS device of claim 1, further comprising ahandle configured for positioning the tMS device over the target bodyarea.
 4. The tMS device of claim 3, wherein the handle includes atouch-sensitive surface and a built-in display configured to communicateuser interactions to a host system and to display an image to a user. 5.The tMS device of claim 1, further comprising a positioning armconfigured for positioning the tMS device over the target body area. 6.The tMS device of claim 1, further comprising a light guide configuredto direct light to a target area to facilitate positioning the tMSstimulator.
 7. The tMS device of claim 1, wherein the tMS stimulatorfurther comprises an accelerometer configured to detect a magnitude anddirection of movement of the tMS stimulator.
 8. The tMS device of claim1, wherein the tMS stimulator further includes a proximity sensorconfigured to determine whether the tMS stimulator is at the target bodyarea.
 9. The tMS device of claim 1, wherein the focused pulse ofmagnetic flux comprises up to approximately 3 Tesla with 20 kTesla/sec.of instantaneous flux within a frequency range of approximately 0.2 Hzto 5 Hz.
 10. A system for treating peripheral nerve pain comprising: atranscutaneous magnetic stimulation (tMS) device including a tMSstimulator configured to deliver a focused pulse of magnetic flux to atarget body area, the tMS stimulator including at least one insulatedmagnetic coil and a capacitor bank of up to 2200 uF energy storagecapacity; and a control module in powered communication with the tMSstimulator configured to control a pulse rate and a magnetic field ofmagnetic flux delivered to the target body area to treat peripheralnerve pain.
 11. The system of claim 10, wherein the at least oneinsulated magnetic coil includes a pair of magnetic coils disposedwithin a housing.
 12. The system of claim 10, further comprising apositioning arm configured for positioning the tMS device over thetarget body area.
 13. The system of claim 10, further comprising a lightguide configured to direct light to a target area when positioning thetMS stimulator.
 14. The system of claim 10, wherein the focused pulse ofmagnetic flux comprises up to approximately 3 Tesla with 20 kTesla/sec.of instantaneous flux within a frequency range of approximately 0.2 Hzto 5 Hz.
 15. A method of treating peripheral nerve pain in a patient inneed thereof using transcutaneous magnetic stimulation (tMS), comprisingthe steps of: positioning a tMS stimulator at a therapeutic positionadjacent a target area of a human body experiencing peripheral nervepain, the tMS stimulator comprising at least one insulated magneticcoil, a capacitor bank of up to 2200 uF energy storage capacity, and acontrol module; and controlling the control module to cause the tMSstimulator to deliver a low frequency magnetic field pulse to the targetarea.
 16. The method of claim 15, wherein the at least one insulatedmagnetic coil includes a pair of coils disposed within a housing. 17.The method of claim 15, wherein positioning comprises manually disposingthe tMS device over the target area using a handheld handle attachedwith the tMS stimulator.
 18. The method of claim 17, wherein the handleincludes a touch-sensitive surface and a built-in display configured tocommunicate user interactions to a host system and to display an imageto a user.
 19. The method of claim 15, wherein positioning comprisesdisposing the tMS device over the target area with a positioning arm.20. The method of claim 15, wherein the low frequency magnetic fieldpulse comprises up to approximately 3 Tesla with 20 kTesla/sec. ofinstantaneous flux within a frequency range of approximately 0.2 Hz to 5Hz.